01 1Gedeon Richter
01 1NORELGESTROMIN USP
01 1Hungary
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-12
Pay. Date : 2019-04-29
DMF Number : 16404
Submission : 2003-02-03
Status : Active
Type : II
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Gedeon Richter Plc, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is NORELGESTROMIN USP, with a corresponding US DMF Number 16404.
Remarkably, this DMF maintains an Active status since its submission on February 03, 2003, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2019, and payment made on April 29, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
